NCT06362265

Brief Summary

The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2024

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

April 9, 2024

Last Update Submit

March 23, 2026

Conditions

Type 2 Diabetes Mellitus

Keywords

Insulin

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590

    Predose up to 65 days post dose

  • PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590

    Predose up to 65 days post dose

Secondary Outcomes (1)

  • Change from Baseline in Fasting Glucose

    Baseline, 65 days

Study Arms (1)

LY3209590

EXPERIMENTAL

LY3209590 administered subcutaneously (SC).

Drug: LY3209590

Interventions

LY3209590DRUG

Administered SC.

LY3209590

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants with Type 2 Diabetes Mellitus (T2DM) for at least 3 months
  • Have Glycated hemoglobin (HbA1c) level of 6.5 percent (%) to 9.5% at screening
  • Have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²)
  • Participants are insulin naïve or have been without insulin treatment for at least 3 months prior to screening

You may not qualify if:

  • Have had a severe hypoglycemia in the past 6 months
  • Have a history of renal impairment
  • Have had a blood transfusion or severe blood loss within last 90 days
  • Have had a significant weight gain or loss of approximately 6% or more within 3 months prior to screening.
  • Have a history of an active or untreated malignancy
  • Are receiving or received systemic glucocorticoid therapy
  • Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, 30329, United States

Location

Centricity Research Columbus Endocrinology

Columbus, Georgia, 31904, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

UBMD Pediatrics

Buffalo, New York, 14203, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Lifedoc Research - Lenox Park Drive

Memphis, Tennessee, 38115, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 12, 2024

Study Start

October 10, 2024

Primary Completion

January 2, 2026

Study Completion

January 2, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(10)